Brief Acceptance-Based Retention Intervention for Newly Diagnosed HIV Patients

Not Applicable

Completed

• Conditions: HIV/AIDS
• Interventions: Behavioral: Enhanced-Treatment-as-Usual (ETAU); Behavioral: Acceptance-Based Behavior Therapy (ABBT)

• Registration Number: NCT04201288
• Lead Sponsor: Brown University

Brief Summary

The overall aim of this program of research is to test a newly developed intervention, Acceptance-Based Behavior Therapy (ABBT), to improve HIV patients' commitment to medical care.

The purpose of the proposed project is to establish the efficacy of ABBT and examine its mechanisms of action. To achieve the specific aims, the investigators will conduct a randomized clinical trial (n = 270), with two treatment arms: ABBT vs. an attention-matched HIV education control condition.

Detailed Description

Drop-out rates from medical clinics in the first months following linkage to HIV care are as high as 50%, with 31-46% of patients dropping out after the first visit. People Living with HIV (PLWH) who are not consistently retained in care are at risk for: delayed antiretroviral treatment (ART) initiation, reduced ART adherence, unsuppressed viremia, and mortality. Moreover, poor retention means effective ART cannot be leveraged to prevent further HIV transmission. The objective of this study is to conduct a fully powered, randomized controlled trial (RCT) to assess the efficacy of a brief, 2-session acceptance-based behavioral therapy (ABBT) intervention to enhance retention in HIV care.

The aims of this proposal are: (1) To test, in a 2-arm RCT, the efficacy of the ABBT intervention on retention in care and virologic suppression (primary outcomes); and, ART adherence, disclosure of HIV status, perceived social support, HIV stigmatization (secondary outcomes), relative to an Enhanced-Treatment-as-Usual condition; and, (2) To examine the degree to which retention in HIV care and virologic suppression are mediated by (a) increased HIV acceptance (and decreased HIV experiential avoidance) and (b) increased willingness to disclose HIV status. The sample will consist of 270 HIV patients who are new to care.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-17
• Study Start: 2020-12-21
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. HIV+
2. ≥18 years old
3. Entering HIV medical care services for the first time (that is, not transferring HIV care from another location)
4. Able to speak and read English at the level to be able to complete the study procedures
5. Have telephone access.

Exclusion Criteria

1. Cognitively impaired

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced-Treatment-as-Usual (ETAU)	Enhanced-Treatment-as-Usual (ETAU)	In addition to receiving treatment-as-usual at the clinic, ETAU participants will receive a 2-session program of HIV education.
Acceptance-Based Behavior Therapy (ABBT)	Acceptance-Based Behavior Therapy (ABBT)	The 2-session ABBT will be delivered in person at session 1 and by telephone at session 2.

Primary Outcome Measures

Name	Time	Method
Retention in medical care	52 weeks	Objective data from participants' electronic health records will be obtained to examine how many medical appointments they attended in the past year at their HIV treatment clinic. Participants will be deemed as sufficiently retained if they attend at least 3 medical visits during this period.
Virologic suppression	52 weeks	Objective data from participants' electronic health records will be obtained to examine their viral load, which is a blood-based measure of the amount of HIV viruses in the person's body. If participants are not currently retained in medical care and blood sample results are not available in their electronic health record, they will submit 1-3ml of blood at each assessment through the study's research phlebotomist.

Secondary Outcome Measures

Name	Time	Method
Self-Rating Scale Item (SRSI) - Antiretroviral Treatment adherence	52 weeks	Self-report data of participants' HIV antiretroviral treatment adherence will be obtained with the SRSI. Scores range from 0 to 5, which correspond to "very poor" to "excellent" medication adherence.
Brief HIV Disclosure and Safer Sex Self-Efficacy Scales (BHD)	52 weeks	The BHD HIV disclosure subscale will be used to assess for willingness to make informed disclosure and for actual disclosure of HIV status. Scores range from 8-32, with higher scores indicating increased willingness to disclose.
HIV Stigma Scale (HSS)	52 weeks	The HSS will be used to measure self-reported experiences, fear, and perception of stigmatization due to being HIV+. Scores range from 6-24, with lower scores indicating less fear or concern about stigmatization.
The Multidimensional Scale of Perceived Social Support (MSPSS)	52 weeks	The MSPSS will be used to measure perceived social support. Scores range from 1-84, with higher scores indicating greater perceived social support.

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States